Devices and methods for anatomic mapping for prosthetic implants

ABSTRACT

A method of generating a patient-specific prosthesis includes receiving anatomic imaging data representative of a portion of a patient&#39;s anatomy. A first digital representation of the anatomic imaging data is defined. The first digital representation of the anatomic imaging data is modified. A second digital representation of the portion of the patient&#39;s anatomy is defined based on the modifying of the first digital representation of the anatomic imaging data. A patient-specific prosthesis is generated based at least in part on the second digital representation of the anatomic imaging data.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/461,911, entitled “Devices and Methods for Anatomic Mapping forProsthetic Implants,” filed Mar. 17, 2017, which is a continuation ofU.S. patent application Ser. No. 15/291,602, now U.S. Pat. No.9,629,705, entitled “Devices and Methods for Anatomic Mapping forProsthetic Implants,” filed Oct. 12, 2016, which is a continuation ofInternational Application No. PCT/US2016/041355, entitled “Devices andMethods for Anatomic Mapping for Prosthetic Implants,” filed Jul. 7,2016, which claims priority to and the benefit of U.S. ProvisionalPatent Application Ser. No. 62/189,918, entitled “Devices and Methodsfor Anatomic Mapping for Prosthetic Implants,” filed Jul. 8, 2015, thedisclosures of which are hereby incorporated by reference in theirentirety

BACKGROUND

The embodiments described herein relate generally to prosthetic implantsand more particularly, to devices and methods for mapping projectedchanges in anatomic features resulting from the placement of aprosthetic implant.

Prosthetic devices are often implanted into, for example, diseasedportions of a patient to repair, support, stent, and/or otherwisefacilitate the proper function of those diseased portions. In someinstances, prosthetic devices such as stent grafts can be used to repairdiseased portions of a patient's vascular system. For example, aneurysmswithin a patient's vascular system generally involve the abnormalswelling or dilation of a blood vessel such as an artery, whichtypically weakens the wall of the blood vessel making it susceptible torupture. An abdominal aortic aneurysm (AAA) is a common type of aneurysmthat poses a serious health threat. A common way to treat AAA and othertypes of aneurysms is to place an endovascular stent graft in theaffected blood vessel such that the stent graft spans across (e.g.,traverses) and extends beyond the proximal and distal ends of thediseased portion of the vasculature. The stent graft can thus reline thediseased vasculature, providing an alternate blood conduit that isolatesthe aneurysm from the high-pressure flow of blood, thereby reducing oreliminating the risk of rupture. In other instances, a prosthetic devicecan be an implant and/or mechanism, which can provide structural orfunctional support to a diseased and/or defective portion of the body.In some instances, however, the arrangement of the anatomy can presentchallenges when attempting to place and/or secure a prosthetic device(including stent grafts or the like). Such challenges can result inmisalignment and/or suboptimal configuration of the prosthetic devicewithin the anatomy.

Therefore, a need exists for improved devices and methods for mappingprojected changes in anatomic features resulting from the placement of aprosthetic implant.

SUMMARY

Devices and methods for improving the fenestration process of stentgrafts are described herein. In some embodiments, a method of generatinga patient-specific prosthesis includes receiving anatomic imaging datarepresentative of a portion of a patient's anatomy. A first digitalrepresentation of the anatomic imaging data is defined. The firstdigital representation of the anatomic imaging data is modified. Asecond digital representation of the portion of the patient's anatomy isdefined based on the modifying of the first digital representation ofthe anatomic imaging data. A patient-specific prosthesis is generatedbased at least in part on the second digital representation of theanatomic imaging data.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a diseased abdominal aorta according to anembodiment.

FIG. 2A is a portion of a stent graft according to an embodiment anddirectly after placement within the diseased abdominal aorta of FIG. 1.

FIG. 2B is a portion of the stent graft of FIG. 2A and placed within thediseased abdominal aorta of FIG. 1 and after a time of indwelling.

FIG. 3 is an illustration of at least a portion of a fenestrated stentgraft according to an embodiment.

FIG. 4 is an illustration of the portion of the fenestrated stent graftof FIG. 3 positioned, for example, within a portion of a diseasedabdominal aorta.

FIG. 5 is a flowchart illustrating a method of forming a prostheticdevice, such as a stent graft, according to an embodiment.

DETAILED DESCRIPTION

Devices and methods for improving the fenestration process of stentgrafts are described herein. In some embodiments, a method of forming apatient-specific prosthesis includes receiving anatomic imaging datarepresentative of a portion of a patient's anatomy. A first digitalrepresentation of the anatomic imaging data is defined. The firstdigital representation of the anatomic imaging data is modified. Asecond digital representation of the portion of the patient's anatomy isdefined based on the modifying of the first digital representation ofthe anatomic imaging data. A patient-specific prosthesis is formed basedat least in part on the second digital representation of the anatomicimaging data.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a member” is intended to mean a singlemember or a combination of members, “a material” is intended to mean oneor more materials, or a combination thereof.

As used herein, the words “proximal” and “distal” refer to a directioncloser to and away from, respectively, an operator of, for example, amedical device. Thus, for example, the end of the medical devicecontacting the patient's body would be the distal end of the medicaldevice, while the end opposite the distal end would be the proximal endof the medical device. Similarly, when a device such as an endovascularstent graft is disposed within a portion of the patient, the end of thedevice closer to the patient's heart would be the proximal end, whilethe end opposite the proximal end would be the distal end. In otherwords, the proximal end of such a device can be upstream of the distalend of the device.

The embodiments described herein can be formed or constructed of one ormore biocompatible materials. Examples of suitable biocompatiblematerials include metals, ceramics, or polymers. Examples of suitablemetals include pharmaceutical grade stainless steel, gold, titanium,nickel, iron, platinum, tin, chromium, copper, and/or alloys thereof.Examples of polymers include nylons, polyesters, polycarbonates,polyacrylates, polymers of ethylene-vinyl acetates and other acylsubstituted cellulose acetates, non-degradable polyurethanes,polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulphonate polyolefins, polyethylene oxide,polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and/orblends and copolymers thereof.

The embodiments and methods described herein can be used to form apatient-specific prosthetic device and/or to facilitate the functionand/or the integration of the prosthetic device within a portion of apatient. For example, in some embodiments, the devices and/or methodsdescribed herein can be used in conjunction with and/or can otherwise beincluded in endovascular repair using stent grafts. Although theembodiments are shown and described herein as being used, for example,to facilitate endovascular repair, in other embodiments, any of thedevices and/or methods described herein can be used to facilitatetreatment of any portion of a patient. For example, the devices andmethods described herein can form and/or can facilitate the integrationof any suitable implant, prosthesis, device, mechanism, machine, and/orthe like within a portion of the body of a patient such as the patient'svascular system, nervous system, muscular-skeletal system, etc.Therefore, while the embodiments are shown and described herein as beingused in the endovascular repair of an abdominal aortic aneurysm, theyare presented by way of example and are not limited thereto.

Some of the devices and/or methods described herein can be used inminimally invasive treatment techniques such as endovascular repairusing stent grafts. Such repair techniques are generally preferred overtraditional open surgical repair and often result in reduced morbidityor mortality rates. In some instances, however, the arrangement of thediseased vasculature can result in a need to alter a portion of thestent graft prior to insertion into the body. For example, in anendovascular repair of an abdominal aortic aneurysm, the aneurysm can besituated adjacent to and/or directly distal to normally functioningvessels branching from a portion of the aorta. In order to reline theaneurysm with the stent graft, surgeons often cut openings in the stentgraft fabric to accommodate specific branch vessel origins, a processknown as “fenestration.” Specifically, in treating juxtarenal aneurysms,for instance, the fenestrations or openings of the stent grafts cancorrespond to a size, shape, and/or relative position of, inter alia,the renal arteries.

Traditionally, the fenestration process involves measurements based onmedical images (such as CT scans) of the vessel origins. For example, insome instances, longitudinal distances of branch vessels can be measuredand relative angular locations of the branch vessels can be estimatedand/or calculated from a reference point. Based on these measurementsand/or calculations, a surgeon can mark and cut the stent fabric of astent graft to define one or more fenestrations. The fenestrated stentgraft can then be positioned within the diseased vasculature (e.g., viaan endovascular procedure) and oriented to substantially align thefenestrations with openings of the corresponding branch vessels.

In some instances, the devices and/or methods described herein can beused to generate and/or otherwise facilitate the formation of afenestrated stent graft based on medical imaging data of a diseasedportion of a patient's vascular system (e.g., an abdominal aorticaneurysm). For example, an electronic device such as a personalcomputer, workstation, laptop, etc. can receive the imaging data and cancalculate and/or otherwise define a digital representation of theimaging data. Based on the digital representation, the electronic devicecan define one or more templates, process plans, instructions, datasets, and/or the like associated with and/or indicative of a desired setof fenestration locations along a stent graft. In some instances, theelectronic device can output a map, plan, and/or template, which inturn, can be used by a doctor, surgeon, technician, and/or manufacturerto form a fenestrated stent graft. For example, in some embodiments,such a template or the like can be substantially similar to thosedescribed in U.S. Patent Publication No. 2013/0296998 entitled,“Fenestration Template for Endovascular Repair of Aortic Aneurysms,”filed May 1, 2013 (“the '998 publication”) and/or those described inU.S. Provisional Patent Application No. 62/151,506 entitled, “Devicesand Methods for Anatomic Mapping for Prosthetic Implants,” filed Apr.23, 2015 (“the '506 application”), the disclosures of which areincorporated herein by reference in their entireties.

As described in further detail herein, in other instances, the devicesand/or methods described herein can be used to form and/or otherwisefacilitate the formation of a fenestrated stent graft without suchtemplates. For example, in some embodiments, the electronic device canoutput instructions and/or code (e.g., machine code such as G-code orthe like) to a computerized numerical control (CNC) device and/or acomputer-aided manufacturing (CAM) device, which in turn, can performone or more manufacturing processes or the like associated with formingand/or otherwise marking fenestration locations along a stent graft. Theformation of the patient-specific prosthesis can be performed in amanual process or in at least a partially automated process. Moreover,the devices and/or methods described herein can be used to determineand/or calculate a change in the arrangement of a portion of the anatomyresulting from the insertion and/or indwelling of the prosthesis, andcan form a patient-specific prosthesis associated with the portion ofthe anatomy thereafter, as described in further detail herein.

FIGS. 1-2B illustrate a diseased portion of a patient's abdominal aorta10. While portions of the abdominal aorta 10 are described below, thediscussion of the abdominal aorta 10 is not exhaustive; rather, thediscussion below provides a reference to the relevant anatomicstructures. Moreover, the discussion of the anatomic structures (e.g.,of the abdominal aorta 10) refers to the position, orientation, etc. ofsuch structures relative to the patient rather than as viewed by anobserver (e.g., a doctor). For example, when referring to a “left” sideof a patient or to anatomic structures disposed on or near the “left”side of the patient, “left” is intended to describe a position relativeto the patient and/or from the patient's perspective, as viewed in ananterior direction (e.g., forward).

The abdominal aorta 10 (also referred to herein as “aorta”) has aproximal end portion 11, receiving a flow of blood from the descendingaorta (not shown), and a distal end portion 12, supplying a flow ofblood to the lower limbs. As shown in FIG. 1, the aorta 10 at or nearthe proximal end portion 11 supplies a flow of blood to the right renalartery 13 and the left renal artery 14, which in turn, supply blood tothe right and left kidney (not shown), respectively. Although not shownin FIG. 1, the proximal end portion 11 of the aorta 10 also supplies aflow of blood to the superior mesenteric artery (SMA) and the celiacartery. The distal end portion 12 of the aorta 10 forms the iliacbifurcation 20, through which the aorta 10 supplies a flow of blood tothe right common iliac artery 15 and the left common iliac artery 16,which in turn, supply blood to the right and left lower limbs,respectively. As shown in FIG. 1, this patient has an abdominal aorticaneurysm (AAA) 17 positioned distal to the renal arteries 13 and 14 andproximal to the iliac bifurcation 20. More specifically, the AAA 17 isdisposed in a position that precludes the attachment of a proximal endportion of a stent graft between the renal arteries 13 and 14 and theAAA 17, and thus, a fenestrated stent graft 160 (see e.g., FIGS. 2A and2B) is used for endovascular repair of the AAA 17.

In some instances, endovascular repair of the AAA 17 includes scanningand/or otherwise capturing anatomic imaging data associated with thepatient's aorta 10. For example, an imaging device can be an X-raydevice, a computed tomography (CT) device, a computed axial tomography(CAT) device, a magnetic resonance imaging device (MRI), a magneticresonance angiogram (MRA) device, a positron emission tomography (PET)device, a single photon emission computed tomography (SPECT) device, anultrasound device, and/or any other suitable device for imaging aportion of the patient and/or a combination thereof (e.g., a CT/MRAdevice, a PET/CT device, a SPECT/CT device, etc.). The imaging datacaptured by the imaging device can thus, be used to determine salientfeatures of the patient's aorta 10 such as, for example, the branchvessels in fluid communication with the aorta 10. For example, a doctor,surgeon, technician, manufacturer, etc. can use the imaging data todetermine and/or calculate a size, shape, position, and/or orientationof the aorta 10, the branch vasculature in fluid communication with theaorta 10 (e.g., the renal arteries 13 and 14), and/or any other suitablevasculature or anatomic structure. In some instances, the doctor,surgeon, technician, manufacturer, etc. can form and/or define one ormore fenestrations 165 in the stent graft 160 associated with thedetermined and/or calculated characteristics of at least the renalarteries 13 and 14.

As shown in FIG. 2A, the stent graft 160 can be positioned within aportion of the patient's abdominal aorta 10 via an endovascularprocedure. For example, the stent graft 160 can be disposed within adelivery catheter (e.g., in a collapsed, compressed, restrained, and/orotherwise un-deployed configuration), which is inserted into, forexample, the femoral artery (not shown). The delivery catheter can beadvanced through the artery and into the abdominal aorta 10. Onceadvanced to a desired position within the abdominal aorta 10, thedelivery catheter can be withdrawn relative to the stent graft 160. Asthe delivery catheter is retracted and/or withdrawn, the stent graft 160transitions from the collapsed configuration to an expanded or deployedconfiguration, thereby stenting a portion of the abdominal aorta 10.

The stent graft 160 includes a proximal end portion 161 and a distal endportion 162 and defines a lumen therethrough 163. The stent graft 160can be any suitable stent graft. For example, the stent graft 160 can beformed from a resilient, biocompatible material such as those describedabove. For example, a stent graft can include a stent or framework towhich a graft material is coupled. In some embodiments, the stent (i.e.,framework) can be constructed from a metal or metal alloy such as, forexample, nickel titanium (nitinol) and the graft material can beconstructed from a woven polymer or fabric such as, for example,polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET orDacron®). In some embodiments, the graft material or fabric can be wovenonto the stent and/or coupled to the stent in any other suitable mannerto form the stent graft (e.g., the stent graft 160).

The stent graft 160 also includes a set of stiffening members 164disposed circumferentially about the stent graft 160. The stiffeningmembers 164 can be any suitable structure that can, for example, biasthe stent graft 160 in an open configuration, thereby structurallysupporting the stent graft material (also known as “stent fabric” or“graft fabric”). In some embodiments, the stiffening members 164 can beformed from a metal or a metal alloy such as, for example, thosedescribed above. In some embodiments, such a metal or metal alloy, forexample, is radiopaque and/or otherwise coated with a radiopaquematerial configured to be visible using, for example, fluoroscopy. Thestiffening members 164 can transition from a restrained or deformeddelivery configuration (e.g., when disposed in a delivery catheter) toan expanded and/or biased indwelling configuration, as shown in FIG. 2A.

In this embodiment, the stent graft 160 defines the set of fenestrations165, as described above. As described herein, the position of thefenestrations 165 along the stent graft 160 can be based on anatomicimaging data and/or one or more digital representations of the patient'sanatomy. A doctor, surgeon, technician, and/or manufacturer can then usethe imaging data and/or digital representations to define thefenestrations 165 in the graft fabric. As shown, in this example, thefenestrations 165 are each aligned with its corresponding renal artery13 or 14 and can each have a size, shape, and/or configuration that isassociated with its corresponding renal artery 13 or 14. In this manner,the fenestrations 165 can allow blood to flow from the aorta 10 and intothe right renal artery 13 and the left renal artery 14 via thefenestrations 165. Although not shown in FIG. 2A, the stent graft 160can define one or more fenestrations associated with other branchvessels stemming from the aorta 10 such as, for example, the superiormesenteric artery (SMA), the celiac artery, and/or the like.

As shown in FIG. 2B, the placement and/or indwelling of the stent graft160 within the aorta 10 can, for example, alter, shift, rotate,translate, morph, and/or otherwise reconfigure the arrangement of thepatient's aorta 10. As a result, the openings of the renal arteries 13and 14 are shifted relative to the fenestrations 165 defined by thestent graft 160. In some instances, the shifting of the aorta 10relative to the stent graft 160 results in at least a partial blockageof the renal arteries 13 and 14, as shown in FIG. 2B. For example, insome instances, the openings of the renal arteries 13 and 14 can beabout 4 millimeters (mm) to about 7 mm, and the shifting and/orrearrangement of the aorta 10 can result in a shifting of the openingsof the renal arteries 13 and 14 relative to the fenestrations 165 byabout 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm,about 7 mm, or more (or fraction of a millimeter therebetween). Thus,despite defining the fenestrations 165 in desired positions along thestent graft 160 based on the imaging data, the shifting of the aorta 10resulting from the placement and/or indwelling of the stent graft 160can result in a blockage of the renal arteries 13 and 14. In someinstances, the shifting of the aorta 10 can result in about a 1%, 5%,10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% (or any percent orfraction of a percent therebetween) blockage of the renal arteries 13and 14. Although not shown in FIGS. 2A and 2B, the shifting of the aorta10 can result in a similar misalignment of any branch vessel relative toits corresponding fenestration in the stent graft 160.

In some embodiments, an electronic device can be configured to determineand/or calculate the shift in the anatomy that would result from theinsertion and/or indwelling of prosthesis (e.g., a stent graft) and candefine one or more digital representations of the shifted anatomy. Forexample, the electronic device can be a personal computer (PC), alaptop, a workstation, and/or the like disposed in a central location ordistributed in multiple locations. The electronic device can include atleast a processor and a memory. In some embodiments, the electronicdevice can also include a display and/or the like. The memory can be,for example, a random access memory (RAM), a memory buffer, a harddrive, a database, an erasable programmable read-only memory (EPROM), anelectrically erasable read-only memory (EEPROM), a read-only memory(ROM), a solid-state drive (SSD), and/or the like. The processor can beany suitable processor configured to run and/or execute a set ofinstructions, for example, stored in the memory. For example, theprocessor can be a general-purpose processor, a Field Programmable GateArray (FPGA), an Application Specific Integrated Circuit (ASIC), aDigital Signal Processor (DSP), a central processing unit (CPU), anaccelerated processing unit (APU), a front-end processor, agraphics-processing unit (GPU), and/or the like. In some embodiments,the memory can store instructions and/or code to cause the processor toexecute modules, processes, and/or functions associated with determiningthe shift in the anatomy, defining a digital representation of theshifted anatomy, and/or forming one or more fenestrations in a stentgraft (e.g., the stent graft 160).

In some embodiments, the digital representation of the shifted anatomycan be a graphical representation of the shifted anatomy that can bepresented on the display of the electronic device. In other embodiments,the digital representation of the shifted anatomy can be an instruction,numeric, and/or machine code representation of the shifted anatomy. Instill other embodiments, the digital representation of the shiftedanatomy can include data associated with a graphical representation andan instruction and/or numeric representation. In addition, the memorycan be configured to store data (e.g., in a database) such as imagingdata, patient data, data associated with the digital representation ofthe anatomy and/or shift anatomy, data associated with the prosthesis(e.g., stent graft), data associated with a template or the like, etc.,as described in further detail herein.

As described above, the electronic device can receive imaging data of aportion of a patient's anatomy and can determine and/or calculate achange in the portion of the patient's anatomy that can result from theimplantation of a prosthetic device. In addition, the electronic devicecan be configured to define a digital representation of the portion ofthe patient's anatomy before and/or after the change in the portion ofthe anatomy. Based on the digital representation of the portion of thepatient's anatomy, the electronic device can define, determine, and/orcalculate one or more positions along a stent graft each of which isassociated with a desired fenestration location in the stent fabric.

For example, an imaging device can be configured to capture and/or scanimaging data associated with a patient's anatomy, as described above.The electronic device can receive the imaging data and can store it inthe memory and/or a database included in and/or coupled to theelectronic device. For example, the electronic device can be incommunication with the imaging device via a wired or wireless network orcombination of networks. In other embodiments, a user can cause theimaging data to be saved to the memory and/or the like (e.g., via a userinterface such as a universal serial bus (USB) port, a Secure Digital(SD) card reader, a disk drive, and/or the like. Once the electronicdevice receives the imaging data, the electronic device can perform anynumber of processes and/or functions associated with analyzing theimaging data to define the digital representation (also referred toherein as “model”) of the imaging data. In some embodiments, theelectronic device can be configured to present the model of the imagingdata on a display and/or the like. In this manner, the electronic devicecan, for example, graphically represent an accurate anatomic model ofthe portion of the patient (e.g., the abdominal aorta). In someinstances, the electronic device can determine salient anatomic featuresand can identify them in the model. The electronic device can thendefine a digital representation that includes only those salientanatomic features, thereby reducing processing load and/or file size.The electronic device can also store any suitable digital representationin the memory and can, for example, associate the digitalrepresentations with the patient (e.g., in a database).

In some instances, based on the model of the imaging data, a portion ofthe model of the imaging data, the model of the salient anatomicfeatures, and/or a combination thereof, the electronic device candefine, for example, one or more positions along a stent graft each ofwhich is associated with a desired fenestration location in the stentfabric of a stent graft. Specifically, as described herein, theelectronic device can define a digital representation of at least aportion of a stent graft, which includes indications of the desiredfenestration locations and/or defines the fenestrations at the desiredlocations according to the patient's anatomy. In some embodiments, theindications can be, for example, protrusions, markers, frangibleportions, and/or any other suitable feature corresponding to, forexample, the openings of the aorta leading to the branch vasculature, asdescribed in further detail herein. Although described above as defininga digital representation of at least a portion of the stent graft, inother embodiments, the electronic device can define a fenestrationtemplate and/or the like that can be substantially similar to any ofthose described in the '998 publication and/or the '506 application,incorporated by reference above.

In some instances, the electronic device can also perform one or moreprocesses to adjust, modify, change, update, augment, morph, and/orotherwise alter the data associated with the model to define an updatedmodel based on a set of characteristics associated with at least one ofthe patient, the prosthesis (e.g., the stent graft), and/or a manner inwhich the prosthesis will be delivered. For example, as described above,the electronic device can be configured to define an updated model basedon the effects of the placement of the prosthesis and its indwellingwithin, for example, the aorta. Said another way, because the anatomy ofat least the abdominal aorta changes when a stent graft is disposedtherein and/or while it is being positioned therein, the electronicdevice is configured to adjust the data associated with the model toaccount for such changes based on characteristics associated with thepatient, the stent graft, and/or the delivery method.

For example, in addition to a mapping (e.g., location information ortopography) of the patient's anatomy, the imaging data can also includeinformation related to any other discernable characteristic identifiedby the imaging technique. Specifically, the imaging data can include,inter alia, a degree of aortic angulation at the juxtarenal neck orother segment of the aorta; a degree, pattern, and location ofatherosclerotic disease including plaque, calcification, and/orthrombus; morphometric characteristics of the vascular structure thatinfluence size, position, angulation, or tortuosity such as vesseldiameter (i.e., vascular lumen diameter); and/or vessel wall thickness,vessel length, location and number of branch arteries, and/or the like.In some embodiments, the electronic device can extract data associatedwith these characteristics and can store the extracted data in thememory (and/or a database). Moreover, the extracted data can be storedwith and/or otherwise associated with other stored patient data and/orstored prosthetic data. For example, the electronic device can storeanthropomorphic data of the patient such as body composition, bodytemperature, height, weight, body-mass index (BMI), abdominalcircumference (absolute or normalized), age, and/or the like;pre-existing vascular or extravascular prostheses or foreign bodies;impact of specific delivery methods such as use of guide wires,catheters, and/or the like; degree of oversizing of the prosthesesrequired to achieve stability; mechanical properties of the prosthesissuch as, for example, body material or fabric type, stent or supportstrut geometry and/or thickness, type of metals or other supportmaterials, stiffness and diameter of the prosthesis and/or devices usedto deliver the prosthesis; and/or the like.

In some instances, the electronic device can determine, evaluate, and/orotherwise calculate a weight, value, score, percentage, scale value,influence measure, impact measure, importance measure, and/or any othersuitable quantifiable evaluation of the data associated with theaforementioned characteristics. Specifically, the electronic device canperform one or more processes, calculations, evaluations, etc. todetermine a quality or measure of impact of the identifiedcharacteristics. For example, in some instances, a first amount ofangulation of a juxtarenal neck can be greater than a second amount ofangulation of a juxtarenal neck. Thus, when a greater angulation of thejuxtarenal neck is indicative of and/or otherwise corresponds to ashifting and/or changing of the aortic arrangement resulting from theplacement of a stent graft, the first amount of angulation can beassociated with a greater value, score, weight, measure, etc., than thesecond amount of angulation.

Expanding further, in at least one embodiment, the electronic device canperform such an analysis based on, for example, a weighted analysis inwhich characteristics and/or factors resulting in a greater amount ofshifting of the aortic anatomy are associated with a greater amount ofweighting than those that affect a lesser amount of shifting. Theweighting of the characteristics can be associated with a value (e.g., amultiplier or the like) such as, for example, a percentage representedin decimal format between zero and one (e.g., 10% represented as 0.1,25% represented as 0.25, 50% represented as 0.5, etc.). In otherinstances, the percentages used in a weighted analysis can be 100% orgreater represented in decimal format (e.g., 125% represented as 1.25,175% represented as 1.75, 200% represented as 2.0, etc.). In still otherinstances, the weighted analysis can be based on any suitable scoringsystem or scale such as, for example, 1-10, 1-100, 1-1000, etc.including whole numbers or fractions thereof.

In some instances, a first set of characteristics can have a greaterweight than a second set of characteristics. For example, in someembodiments, the characteristics extracted from the imaging data can, asa group, have a higher weight than the set of characteristics associatedwith, for example, methods of placing the stent graft, as a group. Inthis manner, the electronic device can perform any suitable evaluation,calculation, determination, etc. of the set of characteristicsassociated with the prosthesis (e.g., the stent graft), the patient,and/or the delivery method of the prosthesis. Moreover, while specificexamples of a weighting system are described, in other embodiments, theelectronic device can perform any suitable weighting and/or evaluatingtechnique. In some embodiments, the characteristics are generallyassociated with a numerical measure (e.g., a stiffness of the prosthesisis a calculable value based on the properties of the material); thus,the electronic device can be configured to use the “intrinsic” orpredetermined values in a predefined equation or the like. Moreover, byquantifying such characteristics, the electronic device can adjustand/or update the data associated with the model to define an updatedmodel based on an anticipated, predicted, predetermined, calculated,and/or otherwise probable shift in the arrangement resulting from theinsertion and/or indwelling of the endovascular stent graft. Saidanother way, the model can be based on a predetermined data set, and thepredetermined data set can be updated based on data associated with ananticipated, predicted, predetermined, calculated, and/or otherwiseprobable shift in the arrangement resulting from the insertion andindwelling of the endovascular stent graft. In some instances, theelectronic device can present the updated model on a display or thelike.

In some instances, the electronic device can determine a combination ofcharacteristics that lead to a desired (e.g., minimal) amount ofanatomic shifting. For example, the electronic device can be configuredto perform and/or execute the evaluation, calculation, and/ordetermination process as described above and can be further configuredto iterate through multiple combinations of characteristics associatedwith the patient, the prosthesis, and/or the delivery method of theprosthesis. As such, the electronic device can determine a combinationof characteristics that will result in a smallest amount of anatomicshifting. For example, in some instances, a stent graft having a firstamount of stiffness can be associated with a first amount of anatomicshifting, while a stent graft having a second amount of stiffness can beassociated with a second amount of anatomic shifting different from thefirst amount. Thus, based on such an analysis, a doctor, surgeon,technician, and/or the like can select a stent graft having a stiffnessthat results in a desired amount of anatomic shift (e.g., generally alesser amount of anatomic shifting), while remaining within, forexample, a range of stent graft stiffness that allows for propertreatment.

As described above, based on the updated model of the imaging data, aportion of the updated model of the imaging data, the model of thesalient anatomic features and/or an updated model of the salientanatomic features, and/or combination thereof, the electronic device candefine, a digital representation, for example, of the stent graft thatdefines the fenestrations and/or includes indications associated withthe fenestrations at the desired locations along the stent graftassociated with the projected, anticipated, adjusted, and/or otherwisecalculated location of the openings of the aorta leading to the branchvasculature. In some instances, the electronic device can include and/orcan be in communication with an output device configured to form and/oroutput at least a portion of the stent graft. For example, the outputdevice can be a printer, a CNC machine, a CAM machine, and/or the likeconfigured to receive instructions and/or code (e.g., G-code) from theelectronic device and to perform one or more processes (e.g.,manufacturing processes) associated with forming the stent graft and/orotherwise defining the fenestrations in the stent graft.

FIG. 3 illustrates at least a portion of a fenestrated stent graft 260according to an embodiment. As described above, a stent graft can defineone or more fenestrations configured to accommodate one or more branchvessels when the stent graft is deployed in an aorta. Specifically, inthis embodiment, the fenestrated stent graft 260 includes a proximal endportion 261 and a distal end portion 262, and defines a lumen 263 and aset of fenestrations 265. The fenestrated stent graft 260 can be anysuitable stent graft and/or prosthesis. For example, in someembodiments, the fenestrated stent graft 260 can be an off-the-shelfstent graft. In other embodiments, the fenestrated stent graft 260 canbe a patient-specific stent graft with a size, shape, and/orconfiguration corresponding to the patient's anatomy.

The fenestrated stent graft 260 (also referred to herein as “stentgraft”) can have any suitable shape, size, and/or configuration. Forexample, in some embodiments, the stent graft 260 can have a size thatis associated with a size of the lumen defined by the aorta. In otherembodiments, the fenestrated stent graft 260 can have a size that isassociated with an adjusted or calculated size of the lumen defined bythe aorta resulting from the endovascular placement of the stent graft260. Moreover, the stent graft 260 can have any suitable mechanicalproperties such as, for example, strength, stiffness, etc.

As shown in FIG. 3, in some embodiments, the stent graft 260 can includestent 264 and a graft fabric 266. The stent 264 can be, for example, anysuitable stent and/or framework configured to increase a stiffness ofthe stent graft 260 and/or to provide structural support for the stentgraft 260. As described above, the stent 264 can be formed from anysuitable metal or metal alloy such as nitinol. In some embodiments, thestent 264 can be configured to transition between a first, expandedand/or implanted configuration and a second, collapsed, and/or deliveryconfiguration. Furthermore, in some instances, the stent 264 can bebiased such that the stent 264 is in the first configuration until aforce is exerted on the stent 264 to transition it from the firstconfiguration to the second configuration (e.g., when disposed in adelivery cannula or the like).

The graft fabric 266 can be formed from any suitable polymer or fabricsuch as, for example, Dacron® or the like. In some embodiments, thegraft fabric 266 can be woven around and/or through the stent 264. Inother embodiments, the graft fabric 266 can be coupled to the stent 264via sutures, a friction fit, or an adhesive, and/or can encapsulate thestent 264 between at least two layers of graft fabric 266. As shown inFIG. 3, the graft fabric 266 defines the fenestrations 265, which can bearranged relative to the stent 264 such that the fenestrations 265 donot overlap the stent 264. In other words, the fenestrations 265 can bearranged along the stent graft 260 such that one or more portions of thestent 264 do not span and/or otherwise traverse the fenestrations 265.In other embodiments, one or more portions of the stent 264 can spanand/or otherwise traverse the fenestration 265. Moreover, as describedin detail above, the fenestrations 265 can be defined by the graftfabric 266 at locations along the stent graft 260 based on an updated,projected, anticipated, and/or otherwise calculated digitalrepresentation of a portion of a patient's vasculature.

As described above, the stent graft 260 can be any suitable stent graftand can be formed via any suitable manufacturing process or processes.In some embodiments, the stent graft 260 can be manufactured as anoff-the-shelf stent graft and the fenestrations 265 can be formed in thegraft material 266 in a subsequent manufacturing process. In otherembodiments, the stent graft 260 can be manufactured as a “custom” ornot-off-the-shelf stent graft. While specific methods of manufacturingare described herein, it is to be understood that the methods arepresented by way of example only and not limitation. Moreover, themethods of manufacturing described herein can be performed at a singlefacility and/or in a single manufacturing process or can be performed atmultiple facilities and/or in multiple manufacturing processes. In someinstances, portions of the methods of manufacturing described herein canbe performed by an end user such as a doctor, surgeon, technician,nurse, etc. Thus, while the manufacturing of the stent graft 260 isspecifically described below, the stent graft 260 can be formed via anysuitable manufacturing process or processes and is not limited to thosediscussed herein.

In some instances, the stent graft 260 can be manufactured with ageneral shape, diameter, length, etc. associated with a patient's aortabased on, for example, calculations from anatomic imaging data of thepatient. In other embodiments, the stent graft 260 can have a generalshape, size, and/or configuration associated with the updated modeldefined by the electronic device, which in turn, corresponds to acalculated, projected, and/or modified arrangement of the aorta inresponse to the insertion and indwelling of, for example, the stentgraft 260, as described in detail above. Hence, a stent graft 260generally has a tubular or cylindrical shape. In some embodiments, thediameter of the lumen 263 is at least partially based on a diameter ofthe calculated, projected, and/or modified lumen defined by the aorta.Moreover, the stent graft 260 can have a stiffness and/or any othersuitable mechanical properties associated with an anticipated amountand/or method of shifting of the aorta resulting from the insertionand/or indwelling of the stent graft 260, as described in detail above.

The fenestrations 265 are defined along the stent graft 260 such thateach fenestration 265 corresponds to a calculated position of thecorresponding branch vasculature such as, for example, the renalarteries. In addition, the stent graft 260 defines and/or can optionallydefine one or more fenestrations 265 corresponding to one of the SMA,the celiac artery, and/or any other branch vasculature. In addition, thediameters of the fenestrations 265 defined by the stent graft 260 cansubstantially correspond to the actual or calculated diameters of theopenings of the branch vessels in fluid communication with a patient'saorta (see e.g., FIG. 4). In other embodiments, the fenestrations 265can have a predefined diameter, for example, between about 2 mm andabout 10 mm. While the stent graft 260 is shown as having fourfenestrations 265, the position and/or number of the fenestrations 265can be arranged in any suitable manner corresponding to the calculatedposition and/or number, respectively, of the branch openings defined bythe patient's aorta. In other words, the size, shape, number, and/orarrangement of the fenestrations 265 defined by the stent graft 260 isbased on the calculated, projected, and/or modified digitalrepresentation of the patient's aorta resulting from the insertionand/or indwelling of the stent graft 260.

The fenestrations 265 can be formed in the graft fabric 266 in anysuitable manner. For example, in some embodiments, the graft fabric 266can be coupled to and/or woven about the stent graft 260 prior to theformation of the fenestrations 265. For example, in some embodiments,the stent graft 260 can be an off-the-shelf stent graft and thefenestrations 265 can be formed in a subsequent manufacturing processand/or the like. As described above, the electronic device is configuredto receive anatomic imaging data of the patient and based oncharacteristics associated with the patient, the stent graft, and/or themanner of inserting the stent graft, can determine and/or define anadjusted and/or updated digital representation of the patient's anatomyassociated with a shifting of the anatomy due to the insertion and/orindwelling of the stent graft 260. In some instances, the electronicdevice can store data associated with the stent graft 260 in the memoryand/or in a database, which in some instances, can include a digitalrepresentation and/or model (e.g., CAD or CAM model) of the stent graft260. As such, the electronic device can also be configured to determineand/or define a digital representation of the stent graft 260 thatincludes the fenestrations 265 and/or indications of the fenestrations265 based on data associated with the projected and/or anticipatedlocation and arrangement of the branch vasculature. As described above,the digital representation of the stent graft 260 (including thefenestrations 265) can be a graphical representation, an instruction,number, and/or a code-based representation, or both.

With the digital representation of the stent graft 260 defined, theelectronic device can be configured to output data associated with thestent graft 260 and/or with forming the fenestrations in the stent graft260. For example, in some embodiments, the electronic device can outputmachine code (e.g., G-code) to a CNC machine and/or CAM machine, whichin turn, can receive the output and can perform one or more associatedmanufacturing processes. For example, in some instances, the electronicdevice can send instructions to a CNC punch, drill, mill, laser cutter,water jet, and/or any other suitable cutting device. In such instances,the stent graft 260 (e.g., without the fenestrations 265) can be loadedinto the machine in an automated, semi-automated, or manual process andcan be supported therein such that an overall shape of the stent graft260 remains substantially constant. For example, a backing plate, orrod, can be inserted through the lumen 263 of the stent graft 260 tosubstantially maintain the stent graft 260 in the first or expandedconfiguration. In addition, the stent graft 260 can be orientedglobally, locally, or both relative to the machine and the machine, forexample, can initialize and/or otherwise register the stent graft 260.

With the stent graft 260 in the desired position and/or orientation andwith the machine initialized or the like, the machine can perform one ormore manufacturing operations associated with forming the fenestrations265 in the graft fabric 266 and/or otherwise providing an indication ofthe fenestrations 265. For example, in some embodiments, the electronicdevice can output instructions to a CNC punch or the like that canperform a punching operation to define the fenestrations 265 in thegraft fabric 266 at the desired and/or calculated locations. Moreover,by positioning, orienting, and/or initializing the machine, thefenestrations 265 can be formed in the graft fabric 266 at positionsother than those where the stent 264 is positioned, as shown in FIG. 3.In other embodiments, one or more fenestration 265 can be positionedsuch that a portion of the stent 264 spans and/or traverses thefenestration 265. In some embodiments, the forming of the fenestration265 can be such that the portion of the stent 264 is substantiallyunaffected (e.g., not cut, deformed, bent, severed, etc.). In otherembodiments, the forming of the fenestration 265 can include cutting,deforming, and/or removing a portion of the stent 264 that wouldotherwise traverse the fenestration 265. In some such embodiments, asupport structure or the like can be coupled (e.g., via sewing, weaving,an adhesive, etc.) to the stent graft 260 to provide support that wouldotherwise be provided by the removed portion of the stent 264. Althoughdescribed as being a CNC punch, in other embodiments, any suitablecutting, punching, puncturing, milling, and/or drilling machine can beused in a substantially similar manner. While described above as formingthe fenestrations 265, in other embodiments, a machine can receive theoutput from the electronic device and in response, can form anindication of the fenestrations 265 on the graft fabric 266. Forexample, in some embodiments, the machine can be configured to sprayand/or otherwise direct paint and/or stain at the locations along thestent graft 260 associated with the fenestrations 265. In suchembodiments, the stent graft 260 can be sold and/or shipped with theindications of the fenestrations 265 and an end user (e.g., doctor,surgeon, technician, etc.) can form the fenestrations in the stent graft260.

In other embodiments, the fenestrations 265 can be formed in asubstantially manual manufacturing process (e.g., a process includinghuman intervention). For example, in some embodiments, the electronicdevice can define the digital representation of the stent graft 260 andcan output data associated with the digital representation, for example,to a projection device or the like (e.g., a laser projector). As such,the projection device can receive the output from the electronic deviceand, in response, can project a visual representation of the stent graft260, including indications of the fenestrations 265, on a predeterminedsurface such as a post, rod, mount, etc. In such instances, amanufacturing technician or the like can position the stent graft 260(e.g., without the fenestrations 265) about the surface and can orientthe stent graft 260 to align at least a portion of the stent graft 260with the projected visual representation of the stent graft 260. Forexample, although not shown in FIG. 3, the stent graft 260 can includean indicator or the like that can be aligned with a correspondingprojected indication. Thus, the projection device can project the visualrepresentation of the stent graft 260 on the physical stent graft 260and the manufacturing technician can form the fenestrations 265 in thedesired locations using any suitable cutting and/or punching device.

Although the manufacturing processes described above have included thegraft fabric 266 coupled to the stent 264 in a manufacturing processprior to forming the fenestrations 265, in other embodiments, thefenestrations 265 can be formed in the graft fabric 266 prior tocoupling to the stent 264. For example, while the stent graft 260 has agenerally cylindrical shape, in some instances, the digitalrepresentation of the stent graft 260 (described above) can include dataassociated with, for example, a flat pattern of the graft fabric 266.That is to say, the electronic device can define data associated withthe graft fabric 266 in a substantially flat configuration with thefenestrations 265 positioned along the graft fabric 266 such that whenthe graft fabric 266 is coupled to the stent 264 (e.g., transitioned toa substantially cylindrical configuration), the fenestrations 265 aredisposed in the desired positions associated with the projected, shiftedpositions of the corresponding branch vasculature. As such, thefenestrations 265 can be formed in the graft fabric 266 by any suitablecutting, punching, drilling, and/or milling operation, in asubstantially similar manner as described above. In other embodiments,the graft fabric 266 can be, for example, printed or the like and candefine the fenestrations 265 in the desired positions along the graftfabric 266. Moreover, once the fenestrations 265 have been formed in thegraft fabric 266, the graft fabric 266 can be disposed about the stent264. In some instances, the graft fabric 266 can be positioned relativeto the stent 264 such that the stent 264 and/or portions thereof do nottraverse the fenestrations 265. The graft fabric 266 can then be coupledto the stent 264 (e.g., via an adhesive or the like). In someembodiments, end portions of the graft fabric 266 can include indiciaand/or other indicators configured to indicate, for example, a diameterof the stent graft 260 when placed in the cylindrical configuration.That is to say, in some embodiments, the end portions of the graftfabric 266 can overlap by a predetermined amount associated with adesired diameter of the stent graft 260. In some embodiments, the endportions of the graft fabric 266 can be coupled via an adhesive and/orcan be sewn together.

In other embodiments, the stent graft 260 can be formed by weaving thegraft fabric 266 and the graft fabric 266 can then be attached to thestent 264. In some embodiments, a weaving and/or sewing machine canreceive instructions from the electronic device associated with weavingthe graft fabric 266 onto the stent 264. In some instances, theinstructions can result in the weaving machine defining thefenestrations 265 by not weaving the graft fabric 266 at positionsassociated with the fenestrations 265. Thus, the fenestrations 265 areformed in the same manufacturing process that otherwise weaves the graftfabric 266.

As shown in FIG. 4, when the fenestrations 265 are defined along thestent graft 260, the stent graft 260 can be positioned within a portionof the patient's body using any suitable endovascular procedure. In thisembodiment, the stent graft 260 is positioned within the patient's aorta10. As shown, the stent graft 260 can include, for example, a first setof fenestrations 265A, which are associated with and/or otherwisecorrespond to the right renal artery 13 and the left renal artery 14.Specifically, each of the fenestrations 265A are aligned with itscorresponding renal artery 13 or 14 and can each have a size, shape,and/or configuration that is associated with its corresponding renalartery 13 or 14. In some embodiments, the size, shape, and/or positionof the fenestrations 265A is associated with and/or substantiallycorresponds to the adjusted and/or calculated size, shape, and/orposition of its corresponding renal artery 13 and 14. For example,placing the stent graft 260 within the aorta 10 can, for example, alter,shift, rotate, translate, morph, and/or otherwise reconfigure thearrangement of the patient's aorta 10. Thus, by basing the stent graft260 off of the updated model, the size, shape, and/or position of thefenestrations 265 defined by the stent graft 260 can correspond to thedesired branch vasculature (e.g., the right renal artery 13 and/or theleft renal artery 14). Moreover, in addition to positioning the stentgraft 260 within a portion of the patient's aorta 10, the renal arteries13 and/or 14 can also be stented, for example, through the fenestrations265A (not shown in FIG. 4). As such, the stent graft 260 and the stentswithin the renal arteries 13 and/or 14 can limit and/or substantiallyprevent migration of the stent graft 260 relative to the patient's aorta10.

As shown in FIGS. 3 and 4, in some embodiments, the stent graft 260 caninclude a second set of fenestrations 265B, which are associated withand/or otherwise correspond to other branch vessels that otherwise,might be blocked by an un-fenestrated portion of the stent graft 260.For example, the fenestrations 265B can be associated with and/orotherwise correspond to the superior mesenteric artery (SMA) 18 and theceliac artery 19, respectively. In other embodiments, the stent graft260 can define fenestrations to accommodate more or fewer branch vesselsthan illustrated here. For example, in some embodiments, the stent graft260 can define fenestrations to accommodate the inferior mesentericartery (IMA), internal iliac arteries, and/or the like. Thus, thefenestrations 265 defined by the stent graft 260 can allow blood to flowfrom the aorta 10 to the branch vasculature, which would otherwise beobstructed by the stent graft 260 material.

In some embodiments, the arrangement of the stent graft 260 and/or thepatient's aorta can be such that a fenestration 265 is partially definedby the stent graft 260. For example, as shown, the proximal mostfenestration 265B is disposed at the proximal end of the stent graft 260and corresponds to the celiac artery 19 that is partially covered by thegraft material during deployment. As such, the fenestration 265B for theceliac artery 19 is partially circular or U-shaped to accommodate theportion of the celiac artery 19 otherwise blocked by the graft material.In other embodiments, any of the fenestrations 265 can have non-circularand/or irregular shapes.

In some embodiments, the fenestrations 265 can be marked to facilitatelocation of the fenestrations 265 during deployment of the stent graft260. For example, the peripheral edges 267A or 267B of the stent graft260 that define the fenestrations 265A or 265B may be sutured using goldwires and/or wires of other radiopaque materials. Similarly, thelocation of the fenestration 265 can be marked by one or more radiopaquemarkers. Such radiopaque wires or markers can facilitate fluoroscopicvisualization of the fenestrations 265 during an endovascular repairprocedure and allow a physician to locate the fenestration 265 withrespect to the corresponding branch vessel. In other embodiments, thefenestrations 265 can be sutured and/or otherwise marked using anysuitable material that can increase visibility, for example, when usingany suitable imaging device (e.g., MRI scan, CAT scan, PET scan, X-Rayscan, ultrasound, etc.). Such markers can be placed and/or sutured inany suitable manufacturing process, which can be combined with orseparate from the formation of the fenestrations 265.

While the stent grafts 160 and 260 have been described above as beingformed via specific manufacturing processes and/or methods, in otherembodiments, portions of the stent grafts 160 and/or 260 and, morespecifically, the fenestrations 165 and 265, respectively, formed in thestent grafts 160 and 260 can be formed after manufacturing. For example,fenestrations in a stent graft can be formed by a healthcareprofessional (e.g., a surgeon and/or the like) after delivery of thestent graft. In such embodiments, a kit including any suitableequipment, tool, instruction, pattern, template, etc. can be deliveredto, for example, a surgeon with the stent graft or independent of thestent graft. In some instances, such a kit can include, tools and/orequipment used, for example, to mark the location of one or morefenestration on a graft fabric, cut, punch, and/or otherwise form thefenestration, suture any portion of the graft fabric (including suturingradiopaque material (e.g., gold) around the peripheral edge of the graftfabric that defines a fenestration, and/or any other suitable equipment.In some embodiments, the kit can include a fenestration template such asthose described in the '998 publication and/or the '506 application,incorporated by reference above. In some embodiments, the kit and/or thecomponents of the kit can be fungible or otherwise disposable (e.g.,after one use).

In some embodiments, the arrangement of such a kit can be such that thecontents of the kit are stored, sold, and/or delivered in asubstantially sterile environment. For example, the kit can be assembledin a substantially sterile environment during a manufacturing processand/or the like and can be sealed such that the components of the kitare in a substantially sterile volume defined by a sealed container orthe like. In some instances, the formation of the fenestrations by, forexample, the surgeon can be performed in a substantially sterileenvironment and then can be positioned within the body of the patient.Thus, by maintaining the sterility of the stent graft prior to delivery,the risk of infection and/or complications associated with the patientcan be reduced.

The components of the kit can include any suitable tool and/orequipment. For example, in some embodiments, the kit can include a toolthat can mark the graft fabric at fenestration locations. The kit canalso include a tool that can cut the graft fabric to form thefenestrations (e.g., a scalpel, a knife, a drill (manual or electricallypowered), a punch, a laser cutter, and/or any other suitable cuttingtool). In some embodiments, the marking tool and the cutting tool can beincluded in the same device. Moreover, in some embodiments, the kit caninclude tools configured to form fenestrations having a predeterminedsize and/or shape, such as, for example, a shape and/or size based atleast in part on imaging data of a portion of the patient. By way ofexample, in some embodiments, a kit can include a cutting tool or bit(e.g., a bit for drilling, punching, burning, etc.), with apredetermined radius or the like, which in turn, can be used to form afenestration in the graft fabric that has a desired and/or predeterminedradius. In some instances, including tools in the kit that are, forexample, patient-specific (e.g., predetermined shape and/or size), canreduce a likelihood of error that otherwise could result from misreadingand/or misinterpreting imaging data.

In some embodiments, the kit can also include a tool that can coupleradiopaque material (e.g., any of those described above) to a portion ofthe graft fabric surrounding or defining the fenestrations. In someembodiments, such a tool can be a means of suturing the material to thegraft fabric such as a suture having one or more radiopaque threads orwires and a suturing needle. In other embodiments, the marking of thefenestrations, the forming of the fenestrations and the coupling of theradiopaque material can be performed using a single tool included in thekit. In some embodiments, the radiopaque markers can be pre-formed(e.g., during a manufacturing process) according to a desired sizeand/or shape of the fenestrations and coupled to the graft fabric via anadhesive or the like, which can reduce an amount of suturing otherwiseperformed by a surgeon.

In some embodiments, the kit can include instructions, a template, amodel, and/or the like that can facilitate the fenestration process. Inthis manner, the kit can include any suitable device, tool, equipment,instruction, template, etc. that can increase the efficiency of thefenestration process, can ensure the fenestrations are placed in desiredpositions, and/or have desired sizes, shapes, and/or arrangements. Insome instances, the tools included in the kit can reduce an amount oftraining and/or skill otherwise desirable for the formation ofpatient-specific fenestrations. Furthermore, the tools included in thekit can limit and/or substantially prevent damage to the stent graft,resulting from forming the fenestrations, that might otherwise changeand/or affect an expected performance of the stent graft (e.g.,fixation, sealing, durability, etc.). In some embodiments, the toolsincluded in the kit can be configured to identify and/or mark portionsof the graft fabric that are removed from the stent graft (e.g., thecutout portions associated with the fenestrations).

In some embodiments, the tools included in the kit can be compatiblewith any suitable stent graft. In other embodiments, the kit can bespecific to a predetermined stent graft (e.g., manufactured by aspecific company and/or according to a size or configuration of thestent graft). In some embodiments, the kit can include the stent graftand any of the tools described above. Moreover, in some embodiments, thekit can include a tool, device, and/or means of placing and maintainingthe stent graft in a delivery (e.g., collapsed) configuration. In someembodiments, the kit can include a tool to adjust, alter, and/or reroutethe position and/or arrangement of a portion of the stent and/or supportstrut (e.g., such that the portion of the stent does not traverse afenestration).

Referring now to FIG. 5, a flowchart is presented illustrating a method1000 of forming a patient-specific prosthesis (e.g., an aortic stentgraft) according to an embodiment. The method 1000 includes receivinganatomic imaging data of a portion of a patient's anatomy (e.g.,including a blood vessel, such as an abdominal aorta, and/or associatedbranch blood vessels), at 1001. In some embodiments, an electronicdevice such as a PC or workstation receives the anatomic imaging data.The electronic device can include a graphic user interface-drivenapplication. The imaging data is from an imaging device in communicationwith the host device such as, for example, an X-ray device, a computedtomography (CT) device, computed axial tomography (CAT) device) amagnetic resonance imaging device (MRI), a magnetic resonance angiogram(MRA) device, a positron emission tomography (PET) device, a singlephoton emission computed tomography (SPECT) device, an ultrasounddevice, and/or any other suitable device for imaging a portion of apatient and/or a combination thereof (e.g., CT/MRA device, PET/CTdevice, SPECT/CT device, etc.). In some embodiments, the imaging devicecan scan and/or otherwise capture imaging data of the patient'sabdominal aorta and/or a portion thereof.

More specifically, the anatomic imaging data of the portion of thepatient's anatomy can be loaded as an input. For example, a user canselect and load a DICOM contrast CT series of the patient abdomen. Insome embodiments, a variety of images can be loaded, including, forexample, computed tomography (CT) images, magnetic resonance (MR)images, and ultrasound (US) images. In some embodiments, two or moreimages of the same image type or of different image types can be fusedto improve image quality, simplify segmentation, and improve measurementaccuracy. For example, in some embodiments, different image types (e.g.,MR and CT) can be geometrically registered to improve segmentation.Additionally, some features of the portion of the patient's anatomy maybe more clearly visible in one image type than another, so fusion of theinformation from two or more images can improve the clarity and accuracyof the images and/or data.

In some embodiments, data can be resampled for improved imageresolution. Data interpolation can be used to improve measurementaccuracy. For example, if images are sampled 2 mm apart along theZ-axis, then the point-to-point distance between two images can only bemeasured in steps of 2 mm. By interpolating between the images (i.e.,creating intermediate images between the two), measurement accuracy canbe improved. As another example, an additional CT image can be createdfrom two CT images spaced 2 mm apart, such that the additional CT imageis placed between the original two CT images and spaced only 1 mm fromeach of the first two CT images. Data interpolation can improve theaccuracy of measurements to, for example, sub-pixel accuracy.

A first digital representation of the anatomic imaging data is defined,at 1002. For example, the electronic device can define the first digitalrepresentation or the like associated with and/or corresponding to thepatient's anatomy. The first digital representation can be, for example,an anatomic model of the patient's abdominal aorta. In some instances,the first digital representation can be an anatomic model of thepatient's abdominal aorta, a first branch blood vessel, and a secondbranch blood vessel based on the anatomic imaging data. Moreover, insome instances, a user can manipulate the electronic device to cause theanatomic model to be graphically presented on a screen using, forexample, a solid modeling program and/or any other computer-aided design(CAD) program.

The images associated with the anatomic imaging data can be displayedsuch that the user can better visualize the patient's anatomy. Theimages can be displayed in a standard layout for 3-D medical images. Forexample, the images can be displayed in a 2×2 layout as axial, sagittal,and coronal slices. The images can also be displayed in a 3-D cube view.In some embodiments, the user can manipulate the images for improvedvisualization of the anatomy. For example, the user can step through theslices, change contrast settings, and change the zoom settings (i.e.,adjust the magnification).

Image processing algorithms can be used to segment the portion of thepatient's anatomy (e.g., the aorta) to focus on the volume of interest.After segmentation, the image data can be cropped to speed up imageprocessing. In some embodiments, the volume of interest can be manuallyentered by a user via a user-selected file or through interactive userinput. In other embodiments, the volume of interest can be determinedautomatically using image analysis techniques. For example, the aortacan be identified in contrast CT images. Image analysis techniques canthen be used to automatically detect a particular portion of the aorta,such as the space ranging from the celiac artery to the renal artery tothe ileac arteries.

In some embodiments, the image processing methods (i.e., image analysistechniques) can determine a sub-volume of interest for furtherprocessing. For example, brightness and/or edge detection can be used todetermine the location of a particular portion of a patient's anatomy,such as the location of the abdominal aorta and branch vessels (e.g.,the renal artery). The location data of the sub-volume of interest canbe used to define the sub-volume of interest such that it contains onlythe data associated with the sub-volume of interest (e.g., a sub-volumeof interest including only the aorta and branch vessels).

In some embodiments, atlas-based methods can be used to model theanatomy to avoid noisy or incomplete data. Such methods begin with theexpected layout of the patient's anatomy, such as the relative locationsof anatomical features and expected ranges of dimensions. For example,for a typical patient, the celiac artery is expected to be positionedabove the renal arteries. Additionally, the diameters of the renalarteries are expected to range from about 4 mm to about 10 mm.

In some embodiments, the method can include modifying the initialanatomical model (i.e., the first digital representation) created fromthe anatomic imaging data using additional data collected through anymethod described herein. Because the initial anatomical model is used asa starting point and the initial anatomical model is then adjusted withcollected data, this method avoids holes in the model that can resultfrom incomplete data. Additionally, noise can be avoided because a useror image processing algorithm can recognize if collected data is withinan expected range of the initial anatomical model. If collected data isoutside of an expected range, the data can be discarded or flagged forreview.

In some embodiments, a combination of user input and automatic detectionis used to define the volume of interest. For example, after an initialautomatic detection using the methods described herein, user input canbe used to refine the boundaries of the volume of interest.

Particular portions of the patient's anatomy, such as the branch vesselsof the aorta, can be automatically segmented. In some embodiments,segmentation can be through “region growing.” For “region growing”segmentation, initial seed points can be user-specified or automaticallydetected. Next, additional nearby data points with similarcharacteristics to the initial seed points can be identified. Similarcharacteristics can include, for example, intensity values. For example,CT images can be quantified using Hounsfield units. An expected range ofHounsfield units for blood vessels in contrast CT images can beidentified. The expected range can be used to identify data points inthe CT images that are likely to be associated with blood vessels. Theinitial seed points and nearby data points with similar characteristicscan be combined to create a model of the particular portion of thepatient's anatomy, such as the branch vessels. In other embodiments, theparticular portion of the patient's anatomy can be automaticallysegmented using deformable models. For example, the boundary of a vesselcan be detected in a first image. The boundary can be, for example,circular or elliptical. The boundary in the first image can be “grown”through the volume of interest (i.e., the boundary shape in the firstimage can be stacked through the volume). Constraints can be imposed onthe overall shape of the “grown” boundary such as, for example,smoothness or orientation. In other embodiments, an atlas-based modelcan be used to segment the vessel. An initial “atlas” model can beconstructed from training data and expert knowledge. Additional data,which may be collected from the patient, can be used to map the initial“atlas” model to the patient's anatomy.

Following segmentation, portions of the patient's anatomy can beextracted from the segmented images. For example, the aortic trunk andthe branch vessels can be segmented and extracted. Morphological filterscan be used to separately extract the aortic trunk and branch vessels.Alternatively or additionally, in some embodiments, elliptical contourscan be fitted to the segmented surface points. Outlier detection methodscan then be used to exclude branch vessel points and only fit pointsthat belong to the main trunk.

In some embodiments, each vessel can be identified using a user'sknowledge of anatomy and patient orientation (e.g., right versus left).For example, the user can distinguish between the left and right renalarteries and between the celiac artery and the superior mesentericartery (SMA). Another example is that the user may know the relativelocations of vessels in a typical anatomy (e.g., the celiac is above therenal arteries) and the user can use this information in identifyingeach vessel. A third example is that the user may intend to identify aportion of the aorta with a specific shape (e.g., a long tube with fourto six branch vessels). Each of the dimensions of the specific shape canhave an expected range of values (e.g., the aorta diameter will bebetween 15 mm and 30 mm). Thus, knowledge of the anatomy can assist withsegmentation and locating, for example, an aneurysm. Additionally,relevant information from the patient's medical record (e.g., a missingrenal artery) can be used.

In some embodiments, centerlines of portions of a patient's anatomy canbe extracted from the segmented portions. For example, the centerlinesof the aortic trunk and branch vessels (i.e. the lines passing throughthe central axes of the aortic trunk and branch vessels and followingthe geometry of the main trunk and branch vessels) can be extracted fromthe segmented portions of the aortic trunk and branch vessels. In someembodiments, the centerlines can be extracted automatically. In someembodiments, a curved planar reformation (CPR) image can be optionallygenerated and displayed. In some embodiments, a distance transform canbe applied to a segmented image and can connect points with maximumdistances using a fast marching method. The distance transform allowsfor distances from each point in the segmented image to the closestneighbor of each point in the background to be computed. For example, ifthe distance transform is applied to a circular contour the distanceswill be maximum at the center and decrease radially. A fast marchingmethod can then be applied to connect points with maximum distances. Inother embodiments, contours (e.g., elliptical, spline, etc.) can be fitto the segmented image and centroids or weighted centroids of thecontours can be computed to define the centerline. In other embodiments,vessel specific properties can be computed and used to computecenterlines. For example, vesselness, a measure of how similar astructure is to tube used in some methods of image segmentation, can becomputed and used to compute centerlines.

The first digital representation of the anatomic imaging data ismodified, at 1003. For example, as described above, the patient'sanatomy can shift, rearrange, and/or otherwise adjust when a prostheticimplant or device such as an endovascular stent graft is disposedtherein. When the portion of the patient's anatomy is a portion of theabdominal aorta, this shifting can result in a corresponding shifting ormovement of the openings to the branch vasculature in fluidcommunication with the aorta, which in turn, can result in a reductionin accuracy of the first digital representation of the anatomic imagingdata relative to the shifted anatomy. Accordingly, in some embodiments,the electronic device can adjust and/or update data associated with thefirst digital representation.

For example, the data can be adjusted and/or updated based on patientdata such as a degree of aortic angulation at the juxtarenal neck orother segment of the aorta; a degree, pattern, and location ofatherosclerotic disease including plaque, calcification, and/orthrombus; morphometric characteristics of the vascular structure thatinfluence size, position, angulation, or tortuosity such as vesseldiameter (i.e., vascular lumen diameter); and/or vessel wall thickness,vessel length, location and number of branch arteries, and/or the like;anthropomorphic data of the patient such as body composition, bodytemperature, height, weight, BMI, abdominal circumference (absolute ornormalized), age, and/or the like; pre-existing vascular orextravascular prostheses or foreign bodies, and/or the like. In someinstances, the data can be adjusted and/or updated based on dataassociated with mechanical properties of the prosthesis such as, forexample, body material or fabric type, stent or support strut geometryand/or thickness, type of metals or other support materials, stiffnessand diameter of the prosthesis, an amount of oversizing of theprosthesis, and/or the like. In addition, the data can be adjustedand/or updated based on data associated with a delivery method of theprosthesis such as, for example, an impact of specific delivery methodssuch as use of guide wires, catheters, and/or the like. A second digitalrepresentation of the portion of the patient's anatomy is defined basedon the modifying of the first digital representation of the anatomicimaging data, at 1004. In other words, the first digital representationof anatomic imaging data can be associated with a portion of thepatient's anatomy in a first configuration and a second digitalrepresentation of the anatomic imaging data can be associated with theportion of the patient's anatomy in a second configuration. The portionof the patient's anatomy can transition from the first configuration tothe second configuration in response to insertion of a prosthetic (e.g.a patient-specific prosthetic).

In some embodiments, the first digital representation of anatomicimaging data can be modified based on a predetermined data set, and thepredetermined data set can be based on data associated with the seconddigital representation. By quantifying characteristics of, for example,a patient-specific prosthetic, a patient, and/or a manner of introducingthe patient-specific prosthetic to a portion of a patient's anatomy, thedata associated with the first digital representation can be adjustedand/or updated to define the second digital representation based on ananticipated, predicted, predetermined, calculated, and/or otherwiseprobable shift in the arrangement resulting from the insertion andindwelling of a prosthetic (e.g., an endovascular stent graft). Saidanother way, the first digital representation can be based on apredetermined data set, and the predetermined data set can be updatedbased on data associated with an anticipated, predicted, predetermined,calculated, and/or otherwise probable shift in the arrangement resultingfrom the insertion and indwelling of the prosthetic.

In some embodiments, the anatomic imaging data can be a first anatomicimaging data set. The modifying of the first digital representation ofthe first anatomic imaging data set can be based on data associated withthe patient-specific prosthetic, a patient, and/or a manner ofintroducing the patient-specific prosthetic to a portion of a patient'sanatomy. The data associated with the patient-specific prosthetic, apatient, and/or a manner of introducing the patient-specific prostheticto a portion of a patient's anatomy can be updated with data associatedwith a second anatomic imaging data set, the second anatomic imagingdata set being representative of the patient-specific prostheticdisposed within the portion of the patient's anatomy.

Specifically, in some embodiments, the modification of the first digitalrepresentation to define a second digital representation of the portionof the patient's anatomy (i.e. the predicted changes in the patient'sanatomy) can be based on predicted changes to the centerline of aportion of the patient's anatomy. For example, the modification can bebased on predicted changes to the extracted centerline of the aortictrunk. The extracted centerline (as described above) is typically asequence of points in 3-D space (e.g., having x-, y-, andz-coordinates). A low order polynomial function can be fitted to thepoints using a least squares fitting technique to produce a modifiedcenterline (i.e., an adjusted centerline) that is a prediction of theshape of the portion of the patient's anatomy after insertion of agraft.

In some embodiments, the modification of the first digitalrepresentation to define a second digital representation of the portionof the patient's anatomy (i.e. the predicted changes in the patient'sanatomy) can be based on the expected deformation of the patient'sanatomy as a result of inserting a device (e.g., a graft) into theanatomy. For example, mathematical models of the segmented volumesand/or surfaces, such as finite element method (FEM) or parametricrepresentations, can be created based on expected deformation of thesegmented volumes and/or surfaces. Models reflecting the expecteddeformation can be built from training data consisting of pre-procedure,intra-procedure, and post-procedure images. The anatomy of interest canbe segmented and the resulting changes can be modeled using machinelearning approaches. In other words, data can be collected from adeformed portion of one or more patients' anatomy (e.g., a deformedaorta) and the data can be used to create a training data set. Thetraining data set can be used to model the predicted deformation of aportion of a patient's anatomy in future procedures.

In some embodiments, the modification of the first digitalrepresentation to define a second digital representation of the portionof the patient's anatomy can take into account characteristics of aparticular device (e.g., a patient-specific prosthetic) to be deliveredto the anatomy. For example, the modification can take into account thewire stiffness of a graft and account for variations in wire stiffnessbetween manufacturers. In some embodiments, for example, a lower orderpolynomial fit can be used to model the predicted change in centerlineif a stiffer device is inserted into the anatomy (e.g. a stiffer graft).Additionally, training data can be used to model changes as a result ofthe characteristics of particular devices.

In some embodiments, the modification of the first digitalrepresentation to define a second digital representation can take intoaccount anatomic-specific information (e.g., characteristics associatedwith a specific patient or set of patients). For example, if theparticular patient's anatomy is unusually angulated, the anatomicalshift of the anatomy as a result of a device being inserted (e.g., agraft) is likely to favor one side of the anatomy (e.g. the aorta vesselwall). Additionally, the insertion location (e.g., left versus rightfemoral artery) can cause the device to favor one side of the anatomy(e.g. aorta vessel wall). Training data can also be used to modelchanges as a result of a particular patient's anatomy. Additionally, insome embodiments, the modification of the first digital representationto define a second digital representation can take into accountprocedure-specific details (i.e., characteristics associated with amethod of introducing a patient-specific prosthetic to the anatomy). Forexample, the modification can account for insertion location (e.g., leftside versus right side), patient breathing, and/or physicianpreferences.

In some embodiments, the user (e.g., clinician or surgeon) can manuallyaccount for patient-specific details (i.e., characteristics associatedwith a patient). For example, a user can use a different method tolocate (for digitally representation) the distal or proximal end of avessel depending on the presence of a calcium deposit. In otherembodiments, the modification of the first digital representation cantake into account patient-specific details using algorithms. Forexample, the modification can account for calcium deposits or plaque,the presence of artifacts obstructing blood flow through the aorta,and/or the angle of curvature of the aorta and branch vessels.

In some embodiments, intra-procedure data can be incorporated to refinealgorithms used to modify the first digital representation. Theintra-procedure data can include imaging data such as fluoroscopy, CT,or any other suitable imaging data. Additionally, in some embodiments,machine learning can be used to refine the algorithms. In someembodiments, intra-procedural data can be used to validate measurementsand refine the algorithms. A model (e.g., a modified digitalrepresentation) can first be used to predict changes in the anatomy orhow the graft would line up along the centerlines of the anatomy. Theintra-procedure data can then be analyzed to observe the actual changes.The deviations from the predicted changes to the actual changes(obtained from intra-procedure data) can in turn be used to refinefuture models (e.g., future digital representations).

For example, patient breathing can deform organs in a non-rigid manner.To account for non-rigid movements, a non-rigid deformation can beapplied to pre-operative models (e.g., a first digital representation).The non-rigid deformation can reflect the amount and shape ofdeformation resulting from a force or forces on a graft caused bypatient breathing. Intra-procedure images of a patient can be analyzedand compared to the patient's pre-operative images to determine theappropriate non-rigid deformation for future digital representations.

As another example, intra-procedure images can be used to modify thefirst representation (i.e. to build a predictive model) based on wherethe device (e.g. a graft) is expected to eventually be located in thepatient based on the side of insertion. For example, grafts that areinserted from the right side of a patient may typically shift to aposition next to the left side of the aorta wall. The expected locationcan be quantified through intra-operative measurements and a predictivemodel can be created.

Calcium deposits along the arterial wall of a vessel can affect thestiffness of the vessel. Additionally, other calcium deposits and/ordiseased portions of the vessel can increase or decrease the stiffnessof the arterial wall. Stiffness of the vessel wall is inversely relatedto the amount of flexibility of the vessel wall. In some embodiments,calcium deposits and/or diseased portions can be accounted for duringthe modification of the first digital representation pre-operatively bymodeling the stiffness as a material property. For example, finiteelement models can be used that model the stiffness as a materialproperty.

When calcium deposits are located near branch vessels, identification ofthe location of the branch vessels can be more difficult. In someembodiments, expert clinician knowledge regarding the location ofcalcium deposits and/or branch vessels can be incorporated into themodification of the first digital representation to define a seconddigital representation. Clinician inputs can be collected and used tomodify the first digital representation (i.e., built into a predictivemodel) that can be applied to future patients and/or procedures. As thenumber of patients in a training set increases, the accuracy of thepredictive model can increase. Additionally, as more data is collectedvia the training set, outlier patient data can be discarded.

In some embodiments, portions of the first digital representation can bemodified to define the second digital representation using a centerlinemodified for the second digital representation as described above (i.e.an adjusted centerline). For example, the branch vessel locations (i.e.,expected locations of the branch vessels during the procedure) can bepredicted using the adjusted centerline of an aorta. As described above,the adjusted centerline can be used to predict the path that the graftwill take within a patient's anatomy. The adjusted branch vessellocations can then be predicted by projecting the vessel endpoints(i.e., the points where the vessels join the aorta which can be obtainedfrom imaging data) on to the adjusted centerline of the aorta.Identification of the branch vessel endpoints (proximal and distal ends)can be performed automatically or manually. To identify the branchvessel endpoints automatically, a segmented vessel surface and asegmented aorta surface can be produced using the segmentation stepsdescribed above. The intersection points of the segmented vessel surfaceand the segmented aorta surface can then be used to locate and definethe branch vessel endpoints (i.e., where the branch vessel connects tothe aorta).

In other embodiments, vessel locations can be predicted by projecting acentral point of the vessel along the adjusted centerline of the aorta.The identification of the central point of the branch vessels can beperformed automatically or manually. To identify the central point ofthe branch vessel automatically, the centerlines for the branch vessels,the main centerline of the aorta, and the segmented aorta produced bythe segmentation steps above can be used to determine the junction point(also referred to as the “branch vessel junction”) where a branch vesselcenterline and an outer surface or wall of the segmented aorta intersect(i.e. the central point of the vessel along the outer surface of theaorta based on the adjusted centerline of the aorta). The vessel radiuscan then be estimated and the vessel location can be defined as ±theradius from the projected branch vessel junction (i.e. the vesselcentral point on the outer surface of the segmented aorta).

In some embodiments, pre-operative images can be deformed (i.e. thefirst digital representation can be modified to define the seconddigital representation) using a deformation field. The deformation fieldcan be created using the output from the finite element models describedabove for deforming the aorta and associated branch vessels. The outputfrom the finite element models is a deformation field with x, y, and zdisplacement values for every voxel in the 3-D image. The deformationfield can then be applied to pre-operative images to deform them theimages will reflect the predicted change in shape of the patient'sanatomy as a result of device insertion. Thus, a user (e.g. a clinicianor a surgeon) can use the deformed images in accounting for deformationsduring pre-procedure planning. Additionally, the deformed images can beused as a training tool for surgical residents to aid in learning aboutintra-operative changes to the shape of the aorta, centerlineadjustment, and the like.

In some embodiments, centerlines (e.g., centerlines of the aortic trunkand branch vessels) can be extracted automatically from mathematicalmodels. Said another way, centerlines can be extracted (using methodsdescribed herein) from deformed images. In such embodiments, centerlinescan be extracted from intra-procedure or post-procedure image datareflecting anatomy deformed by device insertion. Branch vessel locationscan then be predicted based on the extracted centerlines. Similarly asdescribed above, these centerlines can be used for pre-procedureplanning (e.g. modification of the first digital representation todefine a second digital representation) and for training/teaching aids.

A patient-specific prosthetic device is generated based, at least inpart, on the second digital representation of the anatomic imaging data,at 1005. For example, as described above, the electronic device caninclude and/or can send a signal to an output device such as any of themanufacturing device described herein, which in turn, can perform one ormore manufacturing processes to generate the patient-specific prostheticdevice associated with the updated, adjusted, calculated, and/orotherwise modified data (e.g., the second digital representation), whichin turn, is associated with a projected (i.e., predicted), anticipated,and/or calculated arrangement of the patient's abdominal aorta.Specifically, in some embodiments, such a manufacturing device can beconfigured to form one or more fenestrations in a graft fabric, each ofwhich is associated with a position corresponding to a modified and/orshifted position of a branch vessel of the aorta resulting from theplacement of the stent graft, as described in detail above withreference to the patient-specific stent grafts 160 and 260. Thus, thepatient-specific prosthetic device can include openings (fenestrations)corresponding to, for example, the openings of the aorta leading to thebranch vasculature, as described above with reference to, for example,the patient-specific stent grafts 160 and 260. For example, thepatient-specific prosthetic device can include a first fenestration orindicator corresponding to the location of a first branch blood vesselextending from a patient's aorta in the second digital representationand a second fenestration or indicator corresponding to the location ofa second branch blood vessel extending from a patient's aorta in thesecond digital representation.

In some embodiments, the relative locations of the vessels can beautomatically quantified in a 3-D or 4-D coordinate system.Additionally, relevant dimensions such as, for example, diameters andvolume of flow, can be automatically quantified. This information can beused to modify the first digital representation to define the seconddigital representation of the portion of the patient's anatomy. Thesecond digital representation can then be used to create apatient-specific prosthetic device (for example, a patient-specificstent graft). For example, the second digital representation can be usedto create fenestrations in a stent graft at the predicted location ofthe vessels such that fenestrations are at the appropriate location andof an appropriate size and shape to allow pass-through of the vessels.

In some embodiments, for example, a graft fabric of the stent graft canbe a flat sheet configured to be coupled to a stent of the stent graft(transitioned to a substantially cylindrical configuration). Forexample, while the stent graft has a generally cylindrical shape, insome instances, the digital representation of the stent graft (describedabove) can include data associated with, for example, a flat pattern ofthe graft fabric. That is to say, the second digital representation candefine data associated with the graft fabric in a substantially flatconfiguration with the fenestrations positioned along the graft fabricsuch that when the graft fabric is coupled to the stent graft (e.g.,transitioned to a substantially cylindrical configuration), thefenestrations are disposed in the desired positions associated with theprojected, shifted positions of the corresponding branch vasculature.Alternatively, in some embodiments, the second digital representationdata can directly feed into the graft manufacturing process to produce afenestrated graft.

In some embodiments, to form a patient-specific prosthetic device for aportion of a patient's aorta, the average diameter of the aorta atuser-specified end points at the celiac and SMA branch vessels can becomputed. Next, the locations of the branch vessels can be translated tocylindrical coordinates on the surface of a cylinder. The cylinder canhave a diameter equal to the average diameter of the aorta (e.g., theaverage of the diameter at the celiac and the SMA branch vessels). Eachbranch vessel location can be defined by its central point and radius onthe surface of this cylinder as described above.

In some embodiments, clinical knowledge can be incorporated into theprocess of quantifying the relative location of vessels. Clinicalknowledge can be incorporated automatically or manually. For example,information regarding when to block an accessory vessel, when to createa larger fenestration for multiple vessels, how to account for stenosis,visible calcium buildup, and the like, can be used to modify thepatient-specific prosthetic device (e.g., stent graft) based on thesecond digital representation. In some embodiments, for example, anoption can be provided to allow the user to either create a fenestrationin the patient-specific prosthetic device (e.g., stent graft) for anaccessory renal artery or to block off the accessory renal artery andnot provide access through the patient-specific prosthetic device inthat location.

In some embodiments, graft manufacturer data, such as CAD models andstrut patterns, can be incorporated into the second digitalrepresentation and/or the patient-specific prosthetic device. Forexample, manufacturer strut pattern information can be used to definefenestrations in locations on a graft without struts. In someembodiments, the graft manufacturing process can be modified such thatthe strut patterns are customized to not overlap with fenestrationlocations.

Some of the embodiments described herein are configured to define afirst digital representation of anatomic imaging data of a portion of apatient's anatomy and to modify the first digital representation todefine a second digital representation of the portion of the patient'sanatomy based on a set of characteristics associated with the patient, aprosthesis, and/or a manner of delivering the prosthesis. In otherembodiments, the second digital representation of the portion of thepatient's anatomy can be from a plurality of digital representations ofthe portion of patient's anatomy. That is to say, in some embodiments,the modifying of the first digital representation of the portion of thepatient's anatomy can result in a plurality of modified digitalrepresentations of the portion of the patient's anatomy (including thesecond digital representation). In such instances, each modified digitalrepresentation of the portion of the patient's anatomy (simply referredto herein as “modified representation”) can be based on a different setof characteristics or a different combination of the characteristicsassociated with the patient, the prosthesis, and/or the manner ofdelivering the prosthesis.

For example, a first digital representation of a portion of a patient'sanatomy can be modified to define a second digital representation of theportion of the patient's anatomy based on patient data, prosthetic data,and/or a first method of delivering the prosthesis. Similarly, the firstdigital representation of the portion of the patient's anatomy can bemodified to define a third digital representation of the portion of thepatient's anatomy based on the patient data, the prosthetic data, and/ora second method of delivering the prosthesis. In this manner, apatient-specific prosthetic device (e.g., the fenestrated stent grafts160 and 260) based on the second digital representation can also bespecific to the first method of delivering the prosthesis, while apatient-specific prosthetic device based on the third digitalrepresentation can also be specific to the second method of deliveringthe prosthesis. In a similar manner, a digital representation can alsobe based on the size, shape, and/or configuration of the prosthesis. Assuch, a user can input a selection or the like of a digitalrepresentation of a specific prosthetic device from a plurality ofspecific prosthetic devices. Moreover, in some instances, a score,confidence value, rating, and/or any other indicator can be associatedwith the digital representation of each prosthetic device and can beindicative of an accuracy of the digital representation of eachprosthetic device and the associated modified representation of thepatient's anatomy. Said another way, a digital representation of aplurality of patient-specific prosthetic devices and a plurality ofconfidence values can be defined. Each confidence value from theplurality of confidence values can be associated with the digitalrepresentation of a different patient-specific prosthetic device fromthe plurality of patient-specific prosthetic devices and can represent adegree of accuracy between the digital representation of thatpatient-specific prosthetic device and the second digital representationof the anatomic imaging data. Thus, in some instances, a user can selecta digital representation of the prosthetic device with the highest scoresuitable for a patient.

Any of the embodiments described herein can be configured to define amodified representation of a portion of a patient's anatomy based ondata associated with any suitable set of characteristics associated withthe patient, a prosthetic device, a manner of delivery, and/or the like.In some embodiments, the data associated with the set of characteristicscan be updated based on, for example, empirical data and/or the like.For example, in some embodiments, a value, weight, score, factor, and/orthe like can be associated with each characteristic in the set ofcharacteristics. In some instances, anatomic imaging data can be takenof the portion of the patient's anatomy after the delivery of aprosthesis and based on data included in the post-delivery anatomicimaging data the value, weight, score, factor, and/or the likeassociated with the set of characteristics can be updated. In thismanner, the accuracy of a projected change in the portion of the anatomyresulting from the delivery and/or indwelling of a prosthetic device canbe increased based on adjusting and/or “tuning” the weight and/orinfluence of one or more characteristics associated with the patient,the prosthesis, and/or the delivery method.

Some embodiments described herein relate to a computer storage productwith a non-transitory computer-readable medium (also can be referred toas a non-transitory processor-readable medium) having instructions orcomputer code thereon for performing various computer-implementedoperations. The computer-readable medium (or processor-readable medium)is non-transitory in the sense that it does not include transitorypropagating signals per se (e.g., a propagating electromagnetic wavecarrying information on a transmission medium such as space or a cable).The media and computer code (also can be referred to as code) may bethose designed and constructed for the specific purpose or purposes.Examples of non-transitory computer-readable media include, but are notlimited to, magnetic storage media such as hard disks, floppy disks, andmagnetic tape; optical storage media such as Compact Disc/Digital VideoDiscs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), andholographic devices; magneto-optical storage media such as opticaldisks; carrier wave signal processing modules; and hardware devices thatare specially configured to store and execute program code, such asApplication-Specific Integrated Circuits (ASICs), Programmable LogicDevices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM)devices. Other embodiments described herein relate to a computer programproduct, which can include, for example, the instructions and/orcomputer code discussed herein.

Some embodiments and/or methods described herein can be performed bysoftware (executed on hardware), hardware, or a combination thereof.Hardware modules may include, for example, a general-purpose processor,a field programmable gate array (FPGA), and/or an application specificintegrated circuit (ASIC). Software modules (executed on hardware) canbe expressed in a variety of software languages (e.g., computer code),including C, C++, Java™, Ruby, Visual Basic™, and/or otherobject-oriented, procedural, or other programming language anddevelopment tools. Examples of computer code include, but are notlimited to, micro-code or micro-instructions, machine instructions, suchas produced by a compiler, code used to produce a web service, and filescontaining higher-level instructions that are executed by a computerusing an interpreter. For example, embodiments may be implemented usingimperative programming languages (e.g., C, FORTRAN, etc.), functionalprogramming languages (Haskell, Erlang, etc.), logical programminglanguages (e.g., Prolog), object-oriented programming languages (e.g.,Java, C++, etc.), numerical control programing languages (e.g., G-code)or other suitable programming languages and/or development tools.Additional examples of computer code include, but are not limited to,control signals, encrypted code, and compressed code.

Some embodiments and/or methods described herein can be performed bysoftware (executed on hardware), hardware, or a combination thereof andconfigured to process and/or execute one or more programs and/orinstructions stored, for example, in memory. Specifically, some of theembodiments described can be configured to process and/or execute one ormore programs associated with 3-D solid modeling, computer aided design(CAD), volume or surface reconstruction, image analysis and/orsegmentation, and/or the like. Such programs can include but are notlimited to, for example, MATLAB, TeraRecon, FreeCAD, SolidWorks,AutoCAD, Creo, and/or the like. Such programs can be used, for example,to identify features of interest, which can be traced with spline curvesfit to user-specified points. In addition, indicators or markers can beplaced at specific 3-D locations to indicate the origins of the branchvessels. In an embodiment, outlines of the various features or interestand/or origins or branch vessels can be converted to 3-D contours thatdefine the feature locations in the 3-D space. The 3-D contours can beconverted to a mesh to define a 3-D surface model. In some embodiments,segmentation software can be configured to obtain different types ofimaging data such as CT imaging data, ultrasound data, and/or the like.In some embodiments, the size of the generated 3-D surface model can bemodified to optimize the graft fenestration process. For example, thesurface model may be radially expanded to add a predefined wallthickness to allow generation of a patient-specific prosthesis, such asa fenestrated endograft.

In some embodiments, such programs can produce 3-D and multi-planarviews of CT image sets. In some embodiments, such a visualization toolcan perform automatic vessel boundary detection, which can be importedinto segmentation software that generates the 3-D surfaces to expeditethe model generation and hence the fenestration generation process. Insome embodiments, such visualization tools can automatically generate3-D surface data for a digital model and/or a patient-specificprosthesis, such as a fenestrated endograft. Once the vessel boundariesare identified, corresponding openings in the 3-D digital model can becreated and/or defined. In some embodiments, a subtraction between thesolid part model and a cylinder with the desired fenestration diametercan define the openings in the 3-D digital model. In another embodiment,holes representing the origins of branch vessels may be added using aCAD program such as those listed above. In some embodiments, a 3-Ddigital model is converted to a solid object model format such asstereolithography (STL) or Virtual Reality Modeling Language (VRML) thatis supported by a 3-D printer or similar patient-specific prosthesisgeneration device. Advantageously, the availability of automatic aortaboundary detection makes the creation of a patient-specific prosthesis,such as a fenestrated endograft, a practical option for routine use inendovascular aortic aneurysm repair. Raw imaging data or the segmentedaorta boundaries and fenestration locations can be sent to an outsideprocessing facility, and the patient-specific prosthesis can be shippedback to the surgery site. Therefore, individual clinical sites need notemploy individuals with expertise in image segmentation, CAD software,and/or 3-D output devices.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where schematics and/or embodiments described above indicatecertain components arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Although variousembodiments have been described as having particular features and/orcombinations of components, other embodiments are possible having acombination of any features and/or components from any of embodiments asdiscussed above.

Where methods and/or events described above indicate certain eventsand/or procedures occurring in certain order, the ordering of certainevents and/or procedures may be modified. Additionally, certain eventsand/or procedures may be performed concurrently in a parallel processwhen possible, as well as performed sequentially as described above.

What is claimed:
 1. A method of generating a patient-specificprosthesis, comprising: receiving data representative of a firstlocation of an anatomic feature of a patient's blood vessel, the bloodvessel defining a centerline that is a sequence of points inthree-dimensional space; modifying the data representative of the firstlocation to represent the anatomic feature of the patient's blood vesselin a second location, wherein a low-order polynomial function is fittedto the points using a least squares fitting technique to produce amodified centerline, thereby predicting the second location of theanatomic feature of the patient's blood vessel, wherein the secondlocation is different than the first location; and generating apatient-specific prosthesis having a fenestration at the secondlocation.
 2. The method of claim 1, wherein modifying the datarepresentative of the first location is based on predicted deformationof the patient's blood vessel.
 3. The method of claim 2, wherein thepredicted deformation of the patient's blood vessel is based on aproperty of a delivery device for delivering the patient-specificprosthesis to the patient.
 4. The method of claim 3, wherein thedelivery device is a guide wire.
 5. The method of claim 3, wherein thedelivery device is a catheter.
 6. The method of claim 2, wherein thepredicted deformation of the patient's blood vessel is based on aproperty of the patient-specific prosthesis.
 7. The method of claim 6,wherein the property of the patient-specific prosthesis is the stiffnessof the prosthesis.
 8. The method of claim 6, wherein the property of thepatient-specific prosthesis is the diameter of the prosthesis.
 9. Themethod of claim 2, wherein the predicted deformation of the patient'sblood vessel is based on an insertion location of the patient-specificprosthesis.
 10. A method of generating a patient-specific prosthesis,comprising: receiving data representative of a first location of ananatomic feature of a patient's blood vessel, the patient's blood vesseldefining a centerline that is a sequence of points in three-dimensionalspace; predicting a shift in the centerline of the patient's bloodvessel based on the introduction of a medical device into the patient'sblood vessel by fitting a low-order polynomial function to the pointsusing a least squares analysis fitting technique to produce a modifiedcenterline that is a prediction of the shape of the portion of thepatient's anatomy after insertion of a graft; modifying the datarepresentative of the first location of the anatomic feature todetermine a second location of the anatomic feature of the patient'sblood vessel based on the predicted shift in the centerline, the secondlocation different than the first location; and generating apatient-specific prosthesis having a fenestration at the secondlocation.
 11. The method of claim 10, wherein the medical device is aguide wire.
 12. The method of claim 10, wherein the medical device is aprosthesis.
 13. The method of claim 10, wherein the patient's bloodvessel is an aorta.
 14. The method of claim 13, wherein the anatomicfeature is a branch blood vessel.
 15. The method of claim 14, whereinthe fenestration is configured to be aligned with the branch bloodvessel after the patient-specific prosthesis has been implanted into thepatient's aorta.
 16. A method of generating a patient-specificprosthesis, comprising: receiving data representative of a firstlocation of an anatomic feature of a patient's blood vessel, thepatient's blood vessel defining a centerline that is a sequence ofpoints in three-dimensional space; predicting a shift in the centerlineof the patient's blood vessel based on the introduction of a medicaldevice into the patient's blood vessel by fitting a low-order polynomialfunction to the points using a least squares analysis fitting techniqueto produce a modified centerline that is a prediction of the shape ofthe portion of the patient's anatomy after insertion of a graft;modifying the data representative of the first location of the anatomicfeature to determine a second location of the anatomic feature of thepatient's blood vessel based on the predicted shift in the centerline,the second location different than the first location; and receiving astent graft, the stent graft having a fabric graft material disposed ona plurality of support struts; and forming a fenestration in the fabricgraft material at the second location to generate a patient-specificprosthesis.
 17. The method of claim 16, wherein the fenestration isformed in the fabric graft material by at least one of a mechanicalcutting process, a mechanical punching process, a laser cutting process,a water jet cutting process, and/or a drilling process.
 18. The methodof claim 16, further comprising: coupling a radiopaque material to aportion of the patient-specific prosthesis.
 19. The method of claim 18,wherein the radiopaque material is disposed around the fenestration. 20.The method of claim 16, wherein the second location is determined sothat the fenestration can be formed in the fabric graft material in aregion without the support struts.